In late February, San Diego had much more to offer than sun and swaying palm trees. (Although those offerings are highly appealing to us chilled Seattleites.) The Office for Human Research Protections (OHRP) and the University of California, San Diego packed a roster of insightful speakers into the two-day San Diego Research Community Forum (SDRCF). The event occurred at the perfect time, and not just because it allowed us to stroll along the shore in February. It was also an opportune moment to hear about the revised Common Rule from OHRP itself.
The Common Rule, which guides human subjects research for federally funded studies, has undergone significant revision, and OHRP has the lead in implementing it. A bevy of changes was scheduled to go into effect January 19 of this year, but just before that date, OHRP announced it was pushing the effective date out to July 19. The SDRCF offered what for many was the first chance to hear directly from OHRP about that extension.
A Long Silence
Before granting the extension, the government was oddly mute about the major changes defined in the revised Common Rule. This is the first significant revamp of the Common Rule since its introduction in 1991, and the revisions reflect years of debate and consideration. Typically, changes this dramatic would trigger numerous guidance documents to clarify and guide those affected in the months before an implementation date. Public notices would recommend how to reorganize in line with the pending regulations and explain an agency’s expectations on any particulars.
In this case, however, the government remained quiet. No official policy statements appeared in the year between the announcement of the revised Common Rule (January 19, 2017) and its original effective date (January 19, 2018). While numerous sources outside of the government (including Quorum and Kinetiq) summarized the changes and discussed their impacts, those charged with implementing the rules published nothing. No wonder, then, that OHRP’s Dr. Angela Hvitved, Dr. Yvonne Lau, and Deputy Director Julie Kaneshiro attracted standing-room-only audiences at the SDRCF.
Probably the most notable revelation at the conference was that OHRP is considering another extension to the implementation date. Dr. Lau said that an announcement in December 2017 had anticipated this, and that any proposal for an extension past July will appear as a formal Notice of Proposed Rulemaking (NPRM), with an opportunity for public comment. During a question-and-answer session, Dr. Lau added, “Our staff is working on this puzzle. Some people want to push [revised Common Rule implementation] back further, while others were diligent and ready to go and don’t want to be delayed any further. If the NPRM comes out, you may have an opportunity to comment.”
The Common Rule will require widespread changes and new functionality that will surely take months, if not years, to put in place. Local researchers and research institutions have new approval processes to introduce (such as a new limited IRB review focused on privacy and confidentiality safeguards), existing processes to revise (such as the end of continuing review for some types of research), and new protections to introduce (such as broad consent—a tricky alternative consent process for the storage, maintenance, and secondary use of identifiable data or samples).
At the same time, federal agencies that follow the Common Rule have their own tasks to complete. To list a few examples:
- The revised Common Rule will require that researchers post approved consent forms to a publicly available, federal website, but no one has identified a location for these forms. (The government database ClinicalTrials.gov is a likely suspect for that, but the functionality is not there yet.)
- A new standard for informed consent documents presents the concept of a “reasonable person,” but no agency has elaborated on what that implies.
- No agency has released guidance on the new informed consent format of including key information at the beginning, or on the broad consent process.
Clearly, all sides have a lot to do before implementation of the revised Common Rule, which probably explains the delay in the effective date to July 19 and the possibility of another extension. After the effective date—whatever date that ends up being—any new research will need to follow the new regulations. Research that is underway at the time can either change to be in compliance with the revised Common Rule, or it can continue to follow the previous regulations. Anyone who was ready for the revised Common Rule in January had to put new processes and procedures on hold if they conflicted with the current regulations.
Wondering About the Future
In San Diego, the roomful of human subjects research experts showed a clear hunger for details about the revised Common Rule. With no formal guidance, one delay already announced, and another under consideration, attendees lined up at the microphones to ask specifics about implementation. They inquired about broad consent, about the reasonable person standard, about deception in research, and about new review processes. The questions were smart and focused, and the discussion lively. The OHRP speakers also conducted interactive knowledge quizzes, and the audience did pretty well. The issues the group struggled with—notably the use of the new limited IRB review and the guidelines around secondary research—indicate where OHRP may want to concentrate its guidance in the coming months.
The two days passed quickly. As the departing taxis and cars skirted Mission Bay, the sunlight made the water shimmer. The Southern California view temporarily distracted us from our pages of notes and research-related revelations. But our questions about the future of the Common Rule soon returned, and they remain today.
At the San Diego Research Community Forum (SDRCF), the Office for Human Research Protections (OHRP) showcased new videos and infographics for medical research participants. Dr. Yvonne Lau encouraged the attendees to use the new resources to help explain research protections. “Your tax dollars paid for these materials,” she told the audience. The outreach stems from a key element of OHRP’s mission: educating the general public about human subjects research.